Provigil and Nuvigil Linked To Major Congenital Birth Defects: Study

The findings of a new study raise serious concerns about the potential side effects of Provigil and Nuvigil use during pregnancy, indicating the narcolepsy drugs may increase the risk of fetal malformation birth defects.

Researchers from Israel published a research letter this week in the medical journal JAMA Internal Medicine, which warns the rate of major congenital malformations was more than four times higher for births by women taking one of the two drugs than the rate of the general population.

Provigil (modafinil) and Nuvigil (armodafinil) are designed to treat narcolepsy, which is a chronic sleep disorder that causes overwhelming daytime drowsiness. However, the medications are often used off-label to improve cognitive performance, researchers noted. Provigil was first approved for use by the FDA in 1998. Nuvigil was first approved by the FDA in 2007. Both medications are sold by Teva Pharmaceuticals, which sponsored the study.

In 2013 a Nuvigil and Provigil registry was created to track pregnancy and fetal outcomes associated with use of the two drugs. Researchers used data from that registry to track major malformations in this latest research letter.

Researchers used data from 102 prospective live births recorded by the registry between 2013 and 2019. According to the data, they found that 13% of those cases involved major congenital malformations. That is more than four times higher than the rate of 3% among the children of those who did not use either of the narcolepsy drugs.

Among the children born with malformations, three had congenital heart malformations, which, at a prevalence of three percent, is three times higher than the rate of heart malformations among the general populace, which is 1%.

Both drugs are controlled substances in the U.S. due to the risk of abuse and addiction. In addition, they are pregnancy category C drugs, due to the risk of spontaneous abortions and other potential pregnancy risks. However, malformation data has only come from animal studies until now.

The FDA currently recommends both drugs be used during pregnancy only if the potential benefits are greater than the potential side effects.